(20 MMOL/L) POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION USP SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DEXTROSE; POTASSIUM CHLORIDE

متاح من:

BAXTER CORPORATION

ATC رمز:

B05BB02

INN (الاسم الدولي):

ELECTROLYTES WITH CARBOHYDRATES

جرعة:

5G; 150MG

الشكل الصيدلاني:

SOLUTION

تركيب:

DEXTROSE 5G; POTASSIUM CHLORIDE 150MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

1000ML

نوع الوصفة الطبية :

Ethical

المجال العلاجي:

REPLACEMENT PREPARATIONS

ملخص المنتج:

Active ingredient group (AIG) number: 0200305001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2012-12-10

خصائص المنتج

1 of 14
PRESCRIBING INFORMATION
POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
IV Fluid and Nutrient Replenisher
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
March 11, 2021
Submission
Control No: 249296
Baxter, Viaflex and PL 146 are registered trademarks of Baxter
International Inc.
2 of 14
POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
SUMMARY PRODUCT INFORMATION
Potassium Chloride in 5% Dextrose Injection, USP is a sterile,
nonpyrogenic solution for fluid
and electrolyte replenishment and caloric supply in a single dose
container for intravenous
administration. It contains no antimicrobial agents. Composition,
osmolarity,
pH, ionic
concentration and caloric content are shown in TABLE 1.
TABLE 1.
Size
Composition (g/l)
Osmolarity
Ionic Concentration
How
Supplied
Potassium
Chloride in
5%
Dextrose
Injection,
USP
mL
Dextrose
Hydrous,
USP*
Potassium
Chloride,
USP (KCl)
mOsmol/L
pH
Potassium
Chloride
Caloric
Conct.
(kcal/L)
20 mmol/L
1000
50
1.5
292
4.0
20
20
170
40 mmol/L
1000
50
3
332
4.0
40
40
170
*The dextrose is purified from corn and may contain fructose.
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl
chloride (PL
146 Plastic).
Water in a solution in the container can permeate through the plastic
wall, but in an insufficient
amount to significantly
affect the solution. Before the product expires, a very small amounts
of
chemical components of the plastic can be leached into the solution in
the container, such as up
to 5 parts per million
for DEHP. No safety issues of the plastic material were identified in
USP
biological
tests in animals as well as by tissue culture toxicity studies.
ACTIONS
Potassium Chloride in 5% Dextrose Injection, USP has value as a source
of water, electrolytes
and calories. It is capable of inducing diuresis depending on the
clinical condition of the patient.
INDICATIONS AND CLINICAL USE
Potassium Chloride in 5% Dextrose Injection, USP is indicated as a
source of